Status:
TERMINATED
Niacin Plus Statin to Prevent Vascular Events
Lead Sponsor:
Axio Research. LLC
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Abbott
Conditions:
Cardiovascular Diseases
Heart Diseases
Eligibility:
All Genders
45+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether raising "good cholesterol" with a drug based on the vitamin niacin, while lowering "bad cholesterol" with a statin drug, can prevent more heart diseas...
Detailed Description
BACKGROUND: Coronary heart disease (CHD) remains the leading cause of death and disability in the Western world, with approximately 12.6 million individuals in the United States having a history of m...
Eligibility Criteria
Inclusion
- Men and women aged 45 and older with established vascular disease and atherogenic dyslipidemia
- Established vascular disease defined as one or more of the following: (1) documented coronary artery disease (CAD); (2) documented cerebrovascular or carotid disease; (3) documented symptomatic peripheral arterial disease (PAD)
- Atherogenic dyslipidemia defined as: (1) LDL-C of less than or equal to 160 mg/dL (4.1 mmol/L); (2) HDL-C of less than or equal to 40 mg/dL (1.0 mmol/L) for men or less than or equal to 50 mg/dL (1.3 mmol/L) for women; (3) TG greater than or equal to 150 mg/dL (1.7 mmol/L) and less than or equal to 400 mg/dL (4.5 mmol/L)
- For patients entering the trial on a statin: (1) the upper limit for LDL-C is adjusted according to the specific statin and statin dose; (2) HDL-C of less than or equal to 42 mg/dL (1.1 mmol/L) for men or less than or equal to 53 mg/dL (1.4 mmol/L) for women; (3) TG greater than or equal to 125 mg/dL (1.4 mmol/L) and less than or equal to 400 mg/DL (4.5 mmol/L)
Exclusion
- Coronary artery bypass graft (CABG) surgery within 1 year of planned enrollment (run-in phase)
- Percutaneous coronary intervention (PCI) within 4 weeks of planned enrollment (run-in phase)
- Hospitalization for acute coronary syndrome and discharge within 4 weeks of planned enrollment (run-in phase)
- Fasting glucose greater than 180 mg/dL (10 mmol/L) or hemoglobin A1C greater than 9%
- For patients with diabetes, inability or refusal to use a glucometer for home monitoring of blood glucose
- Concomitant use of drugs with a high probability of increasing the risk for hepatotoxicity or myopathy, such as those predominantly metabolized by cytochrome P450 system 3A4, including but not limited to cyclosporine, gemfibrozil, fenofibrate, itraconazole, ketoconazole, HIV protease inhibitors, nefazodone, verapamil, amiodarone; lipid-lowering drugs (other than the investigational drugs) such as statins, bile-acid sequestrants, cholesterol absorption inhibitors (e.g., ezetimibe), fibrates or high-dose, antioxidant vitamins (vitamins C, E, or beta carotene) that can interfere with the HDL-raising effect of niacin
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
3414 Patients enrolled
Trial Details
Trial ID
NCT00120289
Start Date
September 1 2005
End Date
December 1 2012
Last Update
April 6 2016
Active Locations (91)
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1
Cardiovascular Associates, P.C.
Birmingham, Alabama, United States, 35213
2
University of Alabama, Birmingham
Birmingham, Alabama, United States, 35294
3
Clinical Research Consultants, Inc.
Hoover, Alabama, United States, 35216
4
Carl T. Hayden VAMC Phoenix Medical Service
Pheonix, Arizona, United States, 85012